527a3686-fbc6-418b-892e-ead28fd48c3a

SPL v1
SPL
SPL Set ID 527a3686-fbc6-418b-892e-ead28fd48c3a
Route
oral
Published
Effective Date 2023-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
carbonate ion (1000 mg)
Inactive Ingredients
fd&c red no. 40 d&c yellow no. 10 aluminum lake fd&c blue no. 1 aluminum lake fd&c yellow no. 6 magnesium stearate sorbitol 5-methyl-1,3,5-triphenyl-2-pyrazoline

Identifiers & Packaging

Pill Appearance
Imprint: NO Shape: round Color: orange Size: 19 mm Score: 1
Marketing Status
otc monograph final active Since 2023-03-08
Purpose

Antacid

Description

Calcium Carbonate 1000mg

Medication Information

Warnings

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

  • do not take more than 7 tablets in 24 hours.
  • if pregnant do not take more than 5 tablets in 24 hours.
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor. 
Purpose

Antacid

Directions
  • adults and children 12 years of age and over: chew 2-3 tablets as symtoms occur, or as directed by a doctor
  • do not take for symtoms that persist for more than 2 weeks unless advised by a doctor 
Other Information
  • each tablet contains: elemental calcium 400 mg.
  • Store at room temperature. Keep the container tightly closed.
Inactive Ingredients

FD&C Red No.40*, D&C Yellow No.10*, FD&C Blue No.1*, FD&C Yellow No.6*, flavors, magnesium stearate, sorbitol, sucralose (*lake)

Description

Calcium Carbonate 1000mg

Use

Relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms 

Section 50565-1

Keep out of of reach of children

Drug Facts

Product Label

Questions Or Comments?

1-888-309-9030   

Active Ingredient (per Tablet)

Calcium Carbonate 1000mg

Structured Label Content

Warnings

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

  • do not take more than 7 tablets in 24 hours.
  • if pregnant do not take more than 5 tablets in 24 hours.
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor. 
Purpose

Antacid

Directions
  • adults and children 12 years of age and over: chew 2-3 tablets as symtoms occur, or as directed by a doctor
  • do not take for symtoms that persist for more than 2 weeks unless advised by a doctor 
Other Information (Other information)
  • each tablet contains: elemental calcium 400 mg.
  • Store at room temperature. Keep the container tightly closed.
Inactive Ingredients (Inactive ingredients)

FD&C Red No.40*, D&C Yellow No.10*, FD&C Blue No.1*, FD&C Yellow No.6*, flavors, magnesium stearate, sorbitol, sucralose (*lake)

Use (USE)

Relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms 

Section 50565-1 (50565-1)

Keep out of of reach of children

Drug Facts

Product Label (Product label)

Questions Or Comments? (Questions or comments?)

1-888-309-9030   

Active Ingredient (per Tablet) (Active ingredient (per tablet))

Calcium Carbonate 1000mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:36.941828 · Updated: 2026-03-14T23:01:06.342894